|Publication number||US7776091 B2|
|Application number||US 10/881,548|
|Publication date||Aug 17, 2010|
|Filing date||Jun 30, 2004|
|Priority date||Jun 30, 2004|
|Also published as||US8500810, US20060004447, US20070233098|
|Publication number||10881548, 881548, US 7776091 B2, US 7776091B2, US-B2-7776091, US7776091 B2, US7776091B2|
|Inventors||Brooke Mastrorio, Shinikequa Gibson|
|Original Assignee||Depuy Spine, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (12), Referenced by (57), Classifications (6), Legal Events (2)|
|External Links: USPTO, USPTO Assignment, Espacenet|
The leading cause of lower back pain arises from rupture or degeneration of lumbar intervertebral discs. Pain in the lower extremities is caused by the compression of spinal nerve roots by a bulging disc, while lower back pain is caused by collapse of the disc and by the adverse effects of articulation weight through a damaged, unstable vertebral joint.
In some cases, when a patient having a collapsed disc moves in extension (e.g., leans backward), the posterior portion of the annulus fibrosis or folding of the ligamentum flavum may further compress and extend into the spinal canal. This condition, called “spinal stenosis”, narrows the spinal canal and causes impingement of tissue upon the spinal cord and nearby nerves, thereby producing pain.
The “80/20” rule of spine biomechanics postulates that the posterior column of the spine supports about 20% of axial spinal forces. The muscles and ligaments in the posterior column experience tensile forces in normal spine anatomy. However, in some cases of disc replacement, the axial loads borne by the anterior and posterior columns become unbalanced. By developing an implant that re-introduces those natural tensile forces, the 80/20 balance is re-established.
There have been numerous attempts to provide relief for these afflictions by providing a spacer that inserts between adjacent spinous processes present in the posterior portion of the spinal column. This spacer essentially lifts the upper spinous process off of the lower spinous process, thereby relieving stenosis. In general, these interspinous implants are adapted to allow flexion movement in the patient, but resist or limit extension.
U.S. Pat. No. 6,068,630 (“Zuchermann”) discloses a spinal distraction implant that alleviates pain associated with spinal stenosis by expanding the volume in the spinal canal or neural foramen. Zuchermann discloses a plurality of implants having a body portion and lateral wings. The body portion is adapted to seat between the adjacent spinous processes, while the wings are adapted to prevent lateral movement of the body portion, thereby holding it in place between the adjacent spinous processes.
U.S. Pat. No. 5,645,599 (“Samani”) attempts to relieve spinal stenosis by essentially inserting a flexible horseshoe-shaped device between the adjacent spinous processes. Although the Samani device desirably provides a self-limiting flexibility, it nonetheless suffers from some inadequacies. For example, the Samani device does not provide for post-operative adjustment.
In sum, conventional interspinous spacers lack post-operative adjustability.
The present inventors have developed a number of height-adjustable devices suitable for insertion between posterior processes. These devices will give the surgeon the ability to alter the height between adjacent spinous processes by a segmental approach that is minimally invasive.
In a first embodiment, the device comprises a pair of hooks connected to a rod, wherein the hooks are adapted to be translatable along the rod.
In a second embodiment, the devices comprises two parallel plates and a telescoping cylinder-annulus feature therebetween that is movable axially and in the opposite direction from one another.
In a third embodiment, the device comprises a driving mechanism such as an internal gear system that axially separates the upper and lower halves of the implant.
In a fourth embodiment, the device comprises upper and lower insertion holes adapted for receipt of adjustment rods that axially separate the upper and lower halves of the implant.
In a fifth embodiment, the device comprises a threaded projection and a corresponding threaded recess that axially separate the upper and lower halves of the implant. Preferably, one of these components is magnetic, thereby allowing for non-invasive adjustment.
In a sixth embodiment, the device comprises two parallel plates and a bellows therebetween that is axially expandable.
Therefore, in accordance with the present invention, there is provided spinal implant for insertion into a space between adjacent posterior processes, the implant comprising:
For many patients, adjusting the height of the implant would be beneficial because it would alow the surgeon to monitor pain of the patient and adjust the space between adjacent spinous processes, transverse processes or facet joints to relieve pain, or accommodate for growth or changes in the pathologies to be treated.
In some embodiments, the adjustable device of the present invention can also having an angular adjustment component, thereby allowing the surgeon to correct scoliosis, or extreme lordotic or kyphotic curves, by a segmental approach, thereby avoiding a fusion of the anterior column.
Referring now to
As shown in
Because adjustability is desirable only at selected times, it is desirable that the implants of the present invention further contain a means for rendering the height non-adjustable. In preferred embodiments, a locking mechanism (such as a set screw) is positioned to contact the set of teeth on the gear and may be used to essentially stop the ratcheting nature of the rack-and-pinion components.
In one embodiment, the implant further comprises a set screw 45 and the second body has a threaded hole for accommodating a set screw, wherein the threaded hole runs from the outer surface of the second body hook to the gear teeth. Accordingly, the set screw can be percutaneously manipulated in order to allow or prevent height adjustability.
A set screw can also be used to close the gap between the two extending bodies, thereby stopping the rotation of the gear.
In some embodiments, as in
In some embodiments, an actuation rod (not shown) is attached to the center of the gear and extends to the surface of the implant. Therefore, the gear can be actuated by rotating the actuation rod. This allows for percutaneous actuation of the height-adjustable implant. In preferred embodiments, the proximal end portion of the rod has a hexagonal port 49.
In some embodiments, the gear can be magnetic, and thus susceptible to rotation when under the influence of a magnetic field. In such embodiments, there is no need for a driver access port on the implant for actuating the gear.
In preferred embodiment, the bearing surface 33 of one of the bodies extends substantially entirely to the inner side 20 of the opposing extension 18 of the other body. When the bear surface extends so far, the implants maximizes the surface area with which it can support the adjacent processes, thereby minimizing stress upon the implant.
In another embodiment of the present invention using gears to produce translation of opposed surfaces and effect height adjustment, and referring now to
wherein the sets of teeth cooperate such that, upon rotation of the gear, the upper bearing surface moves relative to the second bearing surface, thereby changing the height of the implant.
In some embodiments, as best seen in
In some embodiments (as in
In other embodiments, a dovetail feature may be provided on the first and second bodies for guiding the extension.
In another embodiment of the present invention using a distraction device and translation of opposed surfaces to effect height adjustment, and referring now to
In this embodiment, the slidable reception of the longitudinal projection within the longitudinal recess allows the upper bearing surface to move relative to the second bearing surface, thereby changing the height of the implant.
In use, insertion instruments are inserted into the holes sets and either a) moved toward one another to decrease the height of the device or b) moved away from one another to increase the height of the device. A set screw (not shown) is preferably used to lock and unlock the longitudinal projection/recess assembly.
Now referring to
In some embodiments, as in
As above, this implant may also further contain a means for rendering the height non-adjustable. In preferred embodiments, a set screw may be used to contact each of the annulus and cylinder components to essentially stop the telescoping action.
In some embodiments, the height of the container may be adjusted by altering an amount of fluid disposed within the container cavity. The fluid may be a liquid, gas or gel.
Referring now to
Because the concave bearing portions of the hooks of
In this embodiment, each hook is shown as being slidable along the rod. Having two translatable hooks allows for twice as much of a maximum adjustability length; provides for more adjustment options when working around bony anatomy, and provides both increased flexibility and stability. However, in other embodiments, one of the hooks may be fixed to the central longitudinal body. Requiring that only a single hook be slidable reduces the time required to make the desired height adjustment.
In this embodiment, the concave bearing portion of each hook is shown as being essentially in-line with the rod. This is advantageous because the rod will be under compressive stresses. However, in other embodiments (not shown), the concave bearing portion of each hook may be offset from the rod axis. The offset nature of the hooks is advantageous because it allows the hooks to possess a greater range of travel along the rod.
Because adjustability is desirable only at selected times, it is desirable that the implants of the present invention further contain a means for rendering the height non-adjustable. In preferred embodiments, a locking mechanism, such as set screw 331, is positioned in a threaded bore within a hook, is adapted to contact the rod and may be used to essentially stop the slidable nature of the hooks.
In one embodiment, the implant comprises a set screw and each slidable hook has a threaded hole for accommodating a set screw, wherein the threaded hole runs from the outer surface of the hook to the rod. Accordingly, the set screw can be percutaneously manipulated in order to allow or prevent height adjustability.
In some embodiments, each hook can include a hole on its posterior surface adapted for insetion of a tyne of a forceps instrument. When the tynes are inserted into these holes, manipulation of the separation distances between the tynes adjusts the height of the implant.
In some embodiments, the rod or gear can be magnetic, and thus susceptible to rotation when under the influence of a magnetic field. In such embodiments, the rod preferably includes a first thread that threadably mates with the threaded bore of first hook and a second reverse thread that threadably mates with the threaded bore of the second hook
Now referring to
Referring now to
The devices of the present invention may include conventional actuation means well known to the person of the ordinary skill in the art to adjust the height of the device.
In some embodiments, mechanical actuators are used. In one preferred example, a percutaneous approach is used to deliver the distal end of a driver (e.g., screwdriver or hexdriver) to a port in the device. Upon rotation of the driver, the height of the implant is adjusted. See
Now referring to
a) a first base 411 having an outer bearing surface 413 adapted for fixation to an end of the first spinous process, an inner surface 415 and a first extension 403 extending from the inner surface,
b) an second base 421 having an outer bearing surface 423 adapted for fixation to an end of the second, an inner surface 425, and a recess 405 in the inner surface,
wherein the extension is adapted for slidable reception within the recess
In some embodiments, the device comprises a plurality of holes located substantially on the same face of the implant and on upper and lower portions of the implant. In the case of
Now referring to
In some embodiments, the extension has an outer surface that is smooth. In others the extension has an outer surface that is threaded.
In some embodiments, the implant further comprises a set screw received within the second base and positioned to contact the extension.
In some embodiments, the implant has a magnetic component such that the height adjustment can driven by movement of an external magnet. These embodiments are advantageous because the height adjustment may be accomplished completely non-invasively.
In other embodiments, the device includes an internal motor capable of being powered by an external magnetic field, also allowing height adjustment to be accomplished completely non-invasively.
For example, and now referring to
In preferred embodiments, the slidable action of the upper smooth recess and rod end portion may be checked by a set screw 541 positioned to contact the rod.
In some embodiments, the implant of
In some embodiments, the extension of the implant of
In some embodiments, the implant further comprises a first set screw received within the first base and positioned to contact the rod. In some embodiments, the implant further comprises a second set screw received within the second base and positioned to contact the rod.
In some embodiments, the implant has an expandable container such that the height adjustment can be achieved by adding a fluid to the container, such as a liquid, gas or gel. These embodiments are advantageous because the height adjustment may be accomplished percutaneuously with a high gauge needle.
In some embodiments (now shown), the deep portion of the recess includes a recessed lip projecting outward from the periphery of the recess, and the deep end of the smooth end portion 537 of the rod 531 includes a transverse projection adapted to fit within the lip, but not within the remaining width of the recess. These features provide a stop that insures that the smooth end portion of the rod will not disengage from the recess.
The implants of the present invention may be used in many locations about the posterior portion of the human spine. In some embodiments, the device may be an interspinous device, adapted to be inserted between adjacent spinal processes. In others, the device may be adapted to be inserted between adjacent transverse processes. In others, the device may be adapted to be inserted between adjacent facets defining a facet joint.
In some embodiments, the height-adjustable devices are used in conjunction with a devices placed on the anterior side of the spines, such as a disc replacement device, a nucleus pulposus augmentation device, or a fusion device such as a mesh or a cage. The use of a height-adjustable posterior device with an anteriorly-placed device is advantageous because it provides for a minimally invasive, post-operative correction of problems such as implant subsidence, range of motion, and pain.
The device may also be used for temporal tailoring of physiologic processes. For example, in one embodiment used in conjunction with an anterior device having surfaces adapted for bony ingrowth, the posterior device is inserted in a manner so as to compress the anterior portion of the spine, thereby speeding the bony ingrowth through the anterior device. After such in-growth occurs, the height of the posterior device is adjusted so as to lessen the compression experienced on the anterior portion of the spine.
In other embodiments, the locking mechanism of the device may be loosened to allow for greater freedom of movement of the device.
In some embodiments, the height-adjustable device is implanted at the time of implantation of the disc replacement device or nucleus pulposus augmentation device. In others, the height-adjustable device is implantation at the time of revision of the disc replacement device or nucleus pulposus augmentation device.
In most of the embodiments presented above, the upper and lower bearing surfaces of the device are shown as being essentially flat. In other embodiments, however, these surfaces are shaped to provide greater correspondence with the bony anatomy against which they bear. For example, when the device is an interspinous process, the bearing surfaces may be concave in order to correspond with the convex nature of the opposing spinous processes. In other embodiments adapted for placement within a facet joint, the bearing surfaces have a large radius to correspond with the relatively large radius of the natural facets.
In most of the embodiments presented above, the adjustment results in essentially linear displacement of the upper and lower bearing surfaces of the device. In other embodiments, however, the adjustment meachanisms are adapted to provide angular displacement as well. For example, in some embodiments, the device has corresponding curved sliding surfaces, whereby their relatively movement causes a change in the relative angle of the upper and lower bearing surfaces. In some embodiments, thereof the curved sliding surfaces are fromed by a polyaxial sphere-in-cup arrangement.
Although the locking means set forth above typically present a set screw, other locking means may be employed. In some embodiments, the locking mechanism may be selected from the group consisting of a set screw, a spring-loaded ratchet-and-pawl, a spring-loaded pin-and-detent, and a wedged thread having spring-loaded balls. In some embodiments, the locking mechanism is magnetic, so that the locking and unlocking of the locking mechanism may be accomplished by an external magnet.
The devices of the present invention may be used advantageously in many situations. For example, the height of the implant may be adjusted in order to increase or decrease the spacing between spinous proceses until the desired patient result is obtained. For example, it may be adjusted to shift sections of the vertebral bodies until nerve compression or other pathology is reduced, thereby minimizing pain and obviating the need for other invasive surgical procedures.
The height may be adjusted based upon pain feedback from the patient.
Multiple devices may be used in order to adjust multiple segments in the same session. This would have advantage in the management of scoliosis (as it allows for incremental adjustments over time, and of pain and nerve impingement.
The height of the device may be adjusted to accommodate growth of the patient.
The height of the device may be adjusted to reflect a change in pathology (e.g., as a degenerative disease progresses).
In cases wherein an anterior device has been implanted, the height of the posterior device may be adjusted in order to re-establish the proper 80/20 load sharing balance. As noted above, the device of the present invention may also be used to initially deliberately load a graft placed in the anterior portion of the spine, and then adjusted to release the load once sufficient bone growth has occurred.
In some embodiments, the device of the present invention may include an adjunct feature designed to further patient outcome. For example, in some embodiments, the device may include an injection port for the delivery of medications, such as narcotics. In some embodiments, the device may include electrodes for the facilitation of spinal nerve stimulation or bone growth. In some embodiments, the device may include magnets for bone growth promotion.
In some embodiments of the present invention, MEMS technology sensors and actuators may be incorporated into the device allowing the physician to make adjustments or gather data either automatically or telemetrically.
In some embodiments, a battery may be used to drive the adjustment mechanism of the device. In some embodiments thereof, the battery is located internally, either within or adjacent to the implanted device. In others, the battery is located external to the patient and is electrically connected to the device by a needle.
In some embodiments, the adjustment is actuated by a component having shape memory capabilities. Such components have the ability to superelastically change their shapes in response to a temperature change. Therefore, when a device having a shape memory component is used, the surgeon will be able to adjust the height of the device by simply changing the temperature of the shape memory component.
In some embodiments, the adjustment is actuated by a piezoelectric component. Such components have the ability to vibrate in response to electric current. Therefore, when a device having a piezoelectric component is used, the surgeon will be able to adjust the height of the device by simply vibrating a piezoelectric component adapted to act as an actuator of a threaded component.
The implants of the present invention may be suitably manufactured from any suitable biomaterial, including metals such as titanium alloys, chromium-cobalt alloys and stainless steel) and polymers (such as PEEK, carbon fiber-polymer composites and UHMWPE.
In some embodiments, the device is specifically manufactured for a specific individual. In preferred embodiments thereof, an MRI of the patient is taken, and is used as input to a computer-aided design (CAD) device to produce a device having at least one patient-specific contoured surface. The contouring of that surface may be accomplished conventional methods such as machining or casting.
Because of the dynamic nature of the device of the present invention, in some embodiments, there may be a concern that its expansion may produce a new issue. For example, there may be a concern that expansion produces a newly created void in the device that may undesirably promote tissue ingrowth. In another example, there may be a concern that expansion or height reduction causes impingement of a surface upon a nearby nerve.
Therefore, in some embodiments, the device is encapsulated in an external housing (such as silicone). The housing preferably can be stretched in the amount desired in the expansion without generating undue stress. In one preferred embodiment, the external housing covers a bellows component of the device.
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|Cooperative Classification||A61B2017/00734, A61B17/7065, A61B2017/00867|
|Sep 16, 2004||AS||Assignment|
Owner name: DEPUY SPINE, INC., MASSACHUSETTS
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:MASTRORIO, BROOKE;GIBSON, SHINIKEQUA;REEL/FRAME:015143/0705
Effective date: 20040908
|Jan 22, 2014||FPAY||Fee payment|
Year of fee payment: 4